Neuromodulation for Prevention of Intensive Care Unit Acquired Weakness and Post Intensive Care Syndrome
NCT ID: NCT06238609
Last Updated: 2024-12-30
Study Results
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View full resultsBasic Information
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ACTIVE_NOT_RECRUITING
NA
25 participants
INTERVENTIONAL
2023-08-28
2025-08-28
Brief Summary
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Muscular affection manifested by muscle weakness is particularly seen and is provoked by a combination of damage to the nerves or directly the muscles fibers. This affection is referred to as CU-Acquired Weakness (ICUAW). One third of the time, lower extremities are affected, often due to prolonged immobilization or sedation. Evidence suggests that early mobilization reduces the incidence of ICUAW at discharge and improves the number of patients able of stand. However achieving this early intervention is not always feasible due to time or personnel constraints.
The purpose of the study is to examine the effectiveness of lower extremity neuromodulation for prevention of muscle deconditioning in patients admitted to the ICU.
Detailed Description
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Participants will be randomized to intervention group (IG) or control group (CG). The entire cohort will receive daily neuromodulation in the lower extremity (Gastrocnemius muscle, Achilles tendon) up to 1 hour. The therapy will be provided with a neuromodulation device (Tennant Biomodulator PRO®, AVAZZIA, Inc.) that works on high voltage alternative pulsed current. The device will be functional for the IG and non-functional for the CG.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
Phase I will include patients admitted to the Intensive care Unit. The study duration will be 4 weeks or until hospital discharge, whichever comes first.
SUPPORTIVE_CARE
DOUBLE
Study Groups
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Intervention Group
Subjects will receive a functional neuromodulation device to wear for 1 hour daily up to four weeks or until hospital discharge, whichever came first.
Intervention Group
Subjects will receive a functional neuromodulation device to wear for 1 hour daily up to four weeks or until hospital discharge, whichever came first.
Control group
Subjects will receive a non-functional neuromodulation device to wear for 1 hour daily up to four weeks or until hospital discharge, whichever came first.
Control Group
Subjects will receive a non-functional neuromodulation device to wear for 1 hour daily up to four weeks or until hospital discharge, whichever came first.
Interventions
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Intervention Group
Subjects will receive a functional neuromodulation device to wear for 1 hour daily up to four weeks or until hospital discharge, whichever came first.
Control Group
Subjects will receive a non-functional neuromodulation device to wear for 1 hour daily up to four weeks or until hospital discharge, whichever came first.
Eligibility Criteria
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Inclusion Criteria
* Patient can be intubated with ventilatory assistance or not.
Exclusion Criteria
* Major foot problems such as active lower extremity wounds, major foot deformity (e.g., Charcot Foot), and/or previous major amputations.
* Demand-type cardiac pacemaker, implanted defibrillator, or other implanted electronic devices.
* Any conditions that may interfere with outcomes or increase the risk of the use neuromodulation therapy based on the judgement of clinicians.
18 Years
ALL
No
Sponsors
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Avazzia, Inc
INDUSTRY
Bijan Najafi, PhD
OTHER
Responsible Party
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Bijan Najafi, PhD
Professor of Surgery
Locations
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Baylor College of Medicine
Houston, Texas, United States
Countries
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References
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Zulbaran-Rojas A, Lee M, Bara RO, Flores-Camargo A, Spitz G, Finco MG, Bagheri AB, Modi D, Shaib F, Najafi B. Electrical stimulation to regain lower extremity muscle perfusion and endurance in patients with post-acute sequelae of SARS CoV-2: A randomized controlled trial. Physiol Rep. 2023 Mar;11(5):e15636. doi: 10.14814/phy2.15636.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Document Type: Informed Consent Form
Other Identifiers
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H-52968
Identifier Type: -
Identifier Source: org_study_id